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Posttraumatic Stress DisorderNCT04230668

Cognitive Processing Therapy (CPT) for Posttraumatic Stress Disorder and Borderline Personality Disorder (PTSD-BPD)

A study testing Cognitive Processing Therapy with Suicide Risk Management and Treatment as Usual with Suicide Rick Management in people with Posttraumatic Stress Disorder and Borderline Personality Disorder, run by Palo Alto University at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Posttraumatic Stress Disorder (PTSD) with co-occurring Borderline Personality Disorder (BPD) (i.e., PTSD-BPD) is common (as high as 58%), debilitating, costly, and limited treatment options available for this population. Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
Cognitive Processing Therapy with Suicide Risk Management and Treatment as Usual with Suicide Rick Management
Could I receive a placebo?
No, everyone receives an active treatment
How many people
33 participants
Where
1 siteUnited States
Study dates
1 Oct 2022to 31 Jan 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Aged 18-65 years
  • Must reside in the Bay Area, CA
  • Current DSM-5 diagnosis of PTSD and BPD
  • Must be willing to be audio- or videorecorded for assessment and treatment sessions

Who cannot join

  • Acute mania, acute psychosis, or intellectual disability
  • Conditions requiring medical attention to a potentially life-threatening illness (e.g., severe anorexia nervosa)
  • Severe impairments in written and aural comprehension
  • EU individuals

Trial locations and contacts

1 site in 1 country.

Ariana Guenther, B.A. contact

650-485-1513

bestlab@paloaltou.edu

United States1 site, 1 recruiting
  • Palo Alto University

    Palo Alto, California, 94304

    Ariana Guenther, B.A. (Hons), 650-485-1513, bestlab@paloaltou.edu

    Recruiting

Other trials in United States

About this study

Official title: A Pilot Effectiveness Trial of Cognitive Processing Therapy Augmented With Suicide Risk Management for Individuals With Comorbid PTSD and BPD

Posttraumatic Stress Disorder (PTSD) with co-occurring Borderline Personality Disorder (BPD) (i.e., PTSD-BPD) is common (as high as 58%), debilitating, costly, and limited treatment options available for this population. PTSD-BPD is associated with even greater functional impairment and higher healthcare burden than either disorder alone. There are surprisingly few treatments available for this clinical profile, despite its association with major negative health outcomes, cost, and morbidity. There is a pressing need to innovate treatments that can effectively and efficiently treat PTSD-BPD. The existing treatments used for PTSD-BPD are lengthy, laborious, resource-intensive, and require complete cessation of suicidal behaviors prior to treatment. Furthermore, no integrated treatment has been innovated to deliver the active ingredients to efficiently affect the mechanisms underpinning this comorbidity. The investigators propose to examine an adapted version of a first-line PTSD intervention, Cognitive Processing Therapy, augmented with a Suicide Risk Management, i.e., (CPT+SRM) as a brief (12 sessions) and more parsimonious treatment alternative that strategically targets shared mechanisms underpinning PTSD and BPD. The purpose of this pilot study is to 1) collect initial feasibility, acceptability, and safety data on this adapted treatment, 2) conduct a pilot randomized clinical trial evaluating the efficacy of CPT+SRM versus Treatment as Usual (TAU) + SRM, and 3) evaluate two targets (i.e, improvements in emotional intensity and cognitive dysfunction) as mechanisms leading to change in our primary outcomes. Both treatment conditions will be administered via telehealth.

Potential benefits include reduction in participants' PTSD, BPD and other mental health symptoms. Additionally, this work could benefit the community by improving the treatment repertoire for PTSD-BPD. Potential risks include emotional distress, suicidality, and/or self-harm. Participants may experience discomfort and/or distress while discussing participants trauma(s) and mental health. These risks will be mitigated using a suicide risk management protocol which therapists in the assessment of risk and protective factors of suicide, followed by documentation for the decision-making around the management of risk.

Being tested
Cognitive Processing Therapy with Suicide Risk Management, Treatment as Usual with Suicide Rick Management
Keywords
Cognitive Processing Therapy, Suicide Risk Management, Suicide, Self-harm
Medical subject headings
Stress Disorders, Post-Traumatic, Borderline Personality Disorder, Suicide, Self-Injurious Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cognitive Processing Therapy with Suicide Risk ManagementBehavioural

    CPT is an evidence-based treatment for PTSD. This first-line treatment for PTSD will be adapted and combined with SRM into 12 sessions, 60-90 minutes targeting both PTSD and BPD. Individuals assigned to this intervention will attend treatment sessions, and be asked to do treatment homework at home. The primary outcomes are PTSD and BPD severity.

  • Treatment as Usual with Suicide Rick ManagementBehavioural

    In the Suicide Risk Management only condition, participants will receive 6 weekly sessions over the course of six weeks focused on suicide stabilization and management. Each SRM session will be variable lengths, depending on the participants' suicide risk and can be up to 60 minutes.

Study groups in NCT04230668
Study groupRoleWhat they receive
CPT + SRMExperimentalParticipants will be randomized to teletherapy sessions of Cognitive Processing Therapy + Suicide Risk Management for PTSD-BPD which will be administered twice weekly over 6 weeks, for a total of 12 sessions.
Receives: Behavioral: Cognitive Processing Therapy with Suicide Risk Management
TAU + SRMExperimentalParticipants will be randomized to teletherapy sessions with only Suicide Risk Management for PTSD-BPD which will be administered once a week for 6 weeks, for a total of 6 sessions.
Receives: Behavioral: Treatment as Usual with Suicide Rick Management

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)

    A 30-item clinician administered structured interview based on the DSM-5 PTSD criteria.

    Measured: Baseline, 3-weeks, Post-treatment/6-weeks, 3-months follow-up

  2. Borderline Symptom List 23 (BSL-23) [SELF-REPORT]

    A self-report measure of borderline personality disorder (BPD) severity. The measure captures subjective ratings of the following symptoms: self-perception, affect regulation, self destruction, dysphoria, loneliness, intrusions, and hostility (Bohus et al., 2009).

    Measured: Baseline, once a week while in treatment (for 6 weeks)

Secondary outcomes (27)
  1. Suicide Attempt Self-Injury Interview (SASII)

    Assess characteristics of self-harm (i.e., suicide attempts and NSSI), including frequency, medical severity, intent to die, lethality, and precipitants of self-harm since the previous assessment.

    Measured: 3-weeks, Post-treatment/6-weeks, 3-month follow-up

  2. Difficulties in Emotion Regulation Scale (DERS) [SELF-REPORT]

    A self-report measure assessing various dimensions of emotion dysregulation (Gratz \& Roemer, 2004).

    Measured: Baseline, 3-weeks, Post-treatment/6-weeks, 3-months follow-up

  3. Posttraumatic Cognitions Inventory (PTCI) [SELF-REPORT]

    A 33-item scale assessing post-traumatic symptoms, reactions and appraisals. The measure possesses three subscales; negative cognitions related to the self, negative cognitions related to the world, and self-blame cognitions related to the traumatic event.

    Measured: Baseline, 3-weeks, Post-treatment/6-weeks, 3-months follow-up

  4. Beck's Depression Inventory-II (BDI-II) [SELF-REPORT]

    A 21-item, self-report inventory that measures the severity of depression symptomatology. It corresponds closely to DSM-5 depression criteria and is found to be a more reliable measure of depression (Beck \& Steer, 1988).

    Measured: Baseline, 3-weeks, Post-treatment/6-weeks, 3-months follow-up

  5. State-Trait Anxiety Inventory, Trait Version (STAI-T)

    A measure that consists of 20 items for assessing trait anxiety and 20 for assessing state anxiety. It is used to diagnose anxiety and to help distinguish it from depressive syndromes.

    Measured: Baseline, 3-weeks, Post-treatment/6-weeks, 3-months follow-up

  6. State-Trait Anger Expression Inventory-II (STAXI-II) [SELF-REPORT]

    A 57-item self-report measure that examines the expression, control, and experience of anger (Schamborg, Tully, \& Browne, 2016).

    Measured: Baseline, 3-weeks, Post-treatment/6-weeks, 3-months follow-up

  7. Social Adjustment Scale - Self Report (SAS-SR) [SELF-REPORT]

    A measure that consists of 54 items for assessing role performance in six areas of functioning, including work, social and leisure activities, relationships with extended family, role as a marital partner (if applicable), parental role (if applicable), and role within the family unit.

    Measured: Baseline, 3-weeks, Post-treatment/6-weeks, 3-months follow-up

  8. Trauma-Related Guilt Inventory (TRGI) [SELF-REPORT]

    A 32-item self-report measure that is designed to measure guilt experienced as a result of a traumatic event. It is composed of three subscales including; guilt cognitions, distress and global guilt.

    Measured: Baseline, 3-weeks, Post-treatment/6-weeks, 3-months follow-up

  9. Suicidal Behaviors Questionnaire-Revised

    Scores range from 3 to 18, with 18 being higher suicide risk.

    Measured: Baseline, 3-weeks, Post-treatment/6-weeks, 3-months follow-up

  10. Substance Use Inventory (SUI)

    A brief measure with detailed questions regarding participants' use and primary route of different substances they used in the last seven days. The individuals' are also asked about the average dollar amount spent on each drug and in a single day. (Weiss, et al., 1995).

    Measured: Baseline, 3-weeks, Post-treatment/6-weeks, 3-months follow-up

  11. PTSD Checklist-5 (PCL-5) [SELF-REPORT]

    A 20-item self-report measure that assesses the 20 DSM-5 symptoms of PTSD. It is used to help screen individuals for PTSD as well as monitor their symptom changes during and after treatment.

    Measured: Baseline, once a week while in treatment (for 6 weeks)

  12. Acceptability of Intervention Measure (AIM)

    A 4-item measure which asks therapists and patients about their perceived acceptability of the intervention on a 5-point Likert scale.

    Measured: Baseline and Post-treatment/6-weeks

  13. Treatment sessions attended

    Feasibility as measured by number of treatment sessions

    Measured: Pre-post treatment (6 weeks)

  14. Rate of dropout

    Feasibility as measured by rate of treatment dropout

    Measured: Pre-post treatment (6 weeks)

  15. Emotional Reactivity and Attentional Biases via Oddball task

    Used as a behavioral measure of changes in emotional reactivity and attentional biases- our two propose mechanisms of change in CPT+SRM. The oddball task is computer-based task (Hayes, et al., 2009) designed to measure emotional reactivity and attentional biases. Participants will view a pseudorandom distribution of brief presentations of emotionally-salient distractors (negative images depicting mutilations, burn victims, attacks, sick individuals), neutral distractors (matched with negative images for luminance, presence of human figures, chromatic features), baseline standards (squares), and attention "targets" (circles) in an event-related design. Participants will be instructed to press the same button for all stimuli, but a different button for attention targets. Behavioral changes associated with emotional reactivity and attention bias will be assessed using response latency and accuracy scores for emotional and attention targets, respectively.

    Measured: Baseline, Post-treatment/6-weeks, 3-months follow-up

  16. Mental Health Involvement Scale [SELF-REPORT]

    A 9-item measure used to inquire about other ancillary services (e.g., group treatment, couples/family therapy) that participants are receiving throughout the study. This is a measure developed and used in prior research by the investigative team, but currently does not have published psychometric properties.

    Measured: Post-treatment/6-weeks

  17. Measure of CPT+SRM Uptake [SELF-REPORT]

    Measures uptake of the treatment using an adapted measure from LoSavio, et al. (2019). This brief survey will assess clinicians' ongoing use of CPT+SRM since their participation in the study (e.g., whether they continue to offer CPT+SRM, the number of clients they have offered CPT+SRM to, average number of sessions attended, etc.) and further inform whether our training methods and treatment will have a lasting impact on practice approaches in community settings. There are no psychometric data available for this questionnaire.

    Measured: 9-months after concluding treatment with the last study participant

  18. Unanticipated Problems Involving Risk to Subjects or Others (UPIRSO)

    Safety of the treatment will be monitored via unanticipated problems involving risk to subjects or others (UPIRSO) that occur throughout treatment and the number of mental health hospitalizations.

    Measured: Baseline, 3-weeks, Post-treatment/6-weeks

  19. The International Personality Disorder Exam (IPDE, BPD only)

    A well-established diagnostic instrument used by the World Health Organization, will be used to identify the presence and severity of BPD. The IPDE also allows for a dimensional assessment of BPD.

    Measured: Baseline

  20. The Structured Clinical Interview for the Diagnostic and Statistical Manual-5 (SCID-5)

    Used to obtain other DSM-5 diagnoses.

    Measured: Baseline

  21. The Lifetime Suicide Attempt Self-Injury Interview (L-SASII)

    A semi-structured interview, will assess characteristics of self-harm (i.e., suicide attempts and NSSI), including frequency, medical severity, intent to die, lethality, and precipitants of self-harm.

    Measured: Baseline

  22. A Demographic Form [SELF-REPORT]

    Used in previous PTSD treatment studies will also be used to measure a range of demographic data.

    Measured: Baseline

  23. Trauma-Related Shame Inventory (TRSI) [SELF-REPORT] Trauma-Related Shame Inventory (TRSI) [SELF-REPORT]: is a 24-item self-report measure that evaluates levels of shame in the context of one's trauma. --

    A 24-item self-report measure that evaluates levels of shame in the context of one's trauma.

    Measured: Baseline, 3-weeks, Post-treatment/6-weeks, 3-months follow-up

  24. Patient Health Questionnaire - 9 (PHQ-9)

    A 9-item self-report measure that evaluates severity of depression symptoms.

    Measured: Baseline, 3-weeks, Post-treatment/6-weeks, 3-months follow-up

  25. Generalized Anxiety Disorder - 7 (GAD7)

    A 7-item self-report measure that evaluates severity of generalized anxiety symptoms.

    Measured: Baseline, 3-weeks, Post-treatment/6-weeks, 3-months follow-up

  26. WHO Disability Assessment Schedule (WHODAS) 2.0 (12-Item Version)

    A 12-item self-report measure of disability across six domains (understanding and communicating, getting around, self-care, getting along with people, life activities, and participation in society).

    Measured: Baseline, 3-weeks, Post-treatment/6-weeks, 3-months follow-up

  27. DSM-5-TR Self-Rated Level 1 Cross-Cutting Symptom Measure-Adult

    A 23-item self-report measure of psychiatric symptoms that cut across diagnostic categories.

    Measured: Baseline, 3-weeks, Post-treatment/6-weeks, 3-months follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jan 2020
  2. Study start1 Oct 2022
  3. Primary completion31 Dec 2024 (estimated)
  4. Study completion31 Jan 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
This is a two-phased study. Phase 1 of this investigation will consist of an initial case series in which the CPT+SRM manual will be developed along with fidelity measures. The finalized treatment manual will then be tested in Phase 2, a randomized-controlled trial comparing 12 individual sessions/6 weeks of CPT+SRM versus 6 weeks of TAU+SRM.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
33 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04230668
Sponsor's protocol ID
CPT for PTSD-BPD
Other IDs
1R34MH124968-01A1
Status last verified
Jan 2024
First submitted
9 Jan 2020
Last updated
17 Jan 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Resick, P. A., Monson, C. M., & Chard, K. M. (2016). Cognitive processing therapy for PTSD: A comprehensive manual. New York, NY: Guilford Press.

  • Stanley, B., & Brown, G. (2012). Safety planning intervention: A brief intervention to mitigate suicide risk. Cognitive and Behavioural Practice, 19(2), 256-264.

Questions about this trial

What is this clinical trial studying?

A study testing Cognitive Processing Therapy with Suicide Risk Management and Treatment as Usual with Suicide Rick Management in people with Posttraumatic Stress Disorder and Borderline Personality Disorder, run by Palo Alto University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 17 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Ariana Guenther, B.A. (650-485-1513, bestlab@paloaltou.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) (time frame: Baseline, 3-weeks, Post-treatment/6-weeks, 3-months follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04230668, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2024; AzTrials last refreshed its copy on 27 Oct 2026.

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